Phase II Study of Pembrolizumab After Curative Intent Treatment for Oligometastatic Non-Small Cell Lung Cancer

Abramson Cancer Center at Penn Medicine1 site in 1 country51 target enrollmentJanuary 21, 2015

ConditionsOligometastatic Non-small Cell Lung Cancer (NSCLC)

InterventionsPembrolizumab

DrugsPembrolizumab

Overview

Phase: Phase 2
Intervention: Pembrolizumab
Conditions: Oligometastatic Non-small Cell Lung Cancer (NSCLC)
Sponsor: Abramson Cancer Center at Penn Medicine
Enrollment: 51
Locations: 1
Primary Endpoint: Progression Free Survival (PFS)
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The main purpose of this study is to see how well the experimental drug pembrolizumab (MK-3475) works in people with oligometastatic NSCLC who have already had treatment for their disease. All patients will receive 200 mg of pembrolizumab intravenously on Day 1 of each 21-day cycle. Patients will receive the study drug for up to 8 cycles, and then if their disease is doing well and the study doctor thinks they will benefit patients may receive pembrolizumab for up to 8 more cycles.

Registry

clinicaltrials.gov

Start Date

January 21, 2015

End Date

December 1, 2022

Last Updated

5 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Abramson Cancer Center at Penn Medicine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Provide written informed consent for the trial.
•18 years of age on day of signing informed consent.
•Completion of definitive therapy 4-12 weeks prior to enrollment. There are no specific limitations on which treatment modalities can be used in the definitive setting (e.g. the use of adjuvant chemotherapy is acceptable), but all other treatments must be complete at least 4 weeks prior to enrollment.
•Provision of tissue from an archival tissue sample or newly obtained core or excisional biopsy of a tumor lesion.
•Tumor tissue may be from a diagnostic biopsy or a portion of a surgical specimen, if surgery is a component of definitive intent therapy.
•Formalin fixed paraffin embedded (FFPE) tissue samples are acceptable; a fine needle aspirate, frozen sample, plastic embedded sample, cell block, clot, bone, bone marrow or cytologic specimen will not be acceptable for IHC analysis.
•It is recommended that FFPE blocks be sectioned fresh (within 7 days of sectioning and sending for PD-L1 analysis) onto positively charged slides; slides should be stored and shipped (and stored upon receipt at Qualtek) at 2-8C in the dark.
•Recommended fixation time for samples is 24 hours to 48 hours in 10% neutral buffered formalin.
•Performance status of 0 or 1 on the ECOG Performance Scale.
•Adequate organ function, all screening labs should be performed within 10 days of treatment initiation.

Exclusion Criteria

•Currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks of the first dose of treatment.
•Diagnosis of immunodeficiency or exposure to systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment (Nasal or oral inhalers are permissible).
•Prior monoclonal antibody within 4 weeks prior to study Day 1 or individuals who have not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
•Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Day 1 drug administration on study or inability to recover (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
•Note: Subjects with ≤ Grade 2 neuropathy or alopecia are exceptions to this criterion and may qualify for the study.
•Note: If subject had major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
•Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, non-invasive bladder tumors, or in situ cervical cancer
•Known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis.
•Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections are not excluded from the study. Subjects with hypothyroidism stable on hormone replacement or Sjorgen's syndrome are not excluded from the study.
•Evidence of pre-existing interstitial lung disease or active, non-infectious pneumonitis.